Translational research for recurrent lung cancer treatment with combination therapy of gefitinib and meloxicam

有研究表明，EGFR抑制剂吉非替尼对复发性预处理非小细胞肺癌（NSCLC）有效。COX-II过表达与非小细胞肺癌的预后高度相关。抗癌药物与COX-II抑制剂之间存在一定的协同作用。COX-II的表达与EGFR有关。基于这些结果，我们对非小细胞肺癌进行了II期临床试验，以研究吉非替尼和COX-II抑制剂美洛昔康联合治疗的有效性。【目的】评价吉非替尼与美洛昔康联合治疗的有效率和安全性。【患者】诊断为组织学、良好状态（0-2分）、既往治疗过2个方案且有可测量病变的NSCLC患者符合本研究的条件。【方法】所有患者均给予吉非替尼250mg/美洛昔酸10mg，每日1次，自第1天至PD。【结果】共纳入23例患者。这些患者的背景如下：男性/女性：10/13，组织学；腺癌/鳞状细胞癌/NSCLC: 18/3/2， PS（表现状态）0/1/2:3/18/2，临床分期；III/IV:5/18， MST: 210天。我们没有发现EGFR的表达水平有任何相关性。磷酸化相关EGFR，组织病理染色中COX-II的表达。血浆COX-2、PEG2、PGI2及其他前列腺素水平无相关性。

It has been said that inhibitor of EGFR, gefitinib is effective for reurrent pretreated Non Small Cell Lung Cancer (NSCLC). Overexpression of COX-II is highly related to prognosis for NSCLC. There are some synergism in anticancer agents and COX-II inhibitors. Expression of COX-II is related to EGFR. Based on these results we conducted phase II clinical trial for NSCLC to investigate effectiveness of combination therapy with gefitinib and COX-II inhibitor, meloxicum.【Objectives】 The objective of this study is to evaluate the response rate and safety of combination therapy with gefitinib and meloxicum.【Patients】 NSCLC patients diagnosed with histology, good performance status(0-2), within 2 regimens of prior treatment and having measurable lesions were eligible for this study.【Methods】 All patients were treated with gefitinib 250mg/meloxicum 10 mg once a day from day 1 until PD.【Results】 Twenty three patients were enrolled. Backgrounds for these patients were as follows; male/female: 10/13、histology; adenocarcinoma/squamous cell carcinoma/NSCLC: 18/3/2、PS (performance status) 0/1/2:3/18/2, clinical stage; III/IV:5/18、MST: 210days. We did not see any correlation in expression level of EGFR. Phosphorelated EGFR, expression of COX-II in histopathopogical staining. There were no relation in plasma level of COX-2, PEG2, PGI2 and other prostagrandines.